A double isolation barrier via liner is the best solution to transfer active products from an isolation chamber while ensuring OEB5 to 6 performances. CSV Containment, with its wide range of liner products, can offer these customized coaxial containment solutions.
In double isolation barrier systems, both rigid or flexible chambers receive a first liner to be separated. The first liner separates inside the chamber and is then transferred to the outside of the chamber through a second liner, thus obtaining a double isolation barrier.
Transferring active products from an isolation chamber to the outside requires a level of safety that is unlikely to be achieved by solutions other than the double barrier. Indeed, mechanical separation systems produce a degree of containment OEB4. Heat sealing, the only real alternative, has some practical criticalities and requires characteristics suitable for working environments, such as operating in an ATEX environment.
When it is necessary to exit an isolation chamber with an OEB5 containment grade, therefore, there is a tendency to achieve double isolation through a coaxial liner system with suitable characteristics to facilitate the double operation. The first liner is discharged inside the chamber to be transferred to a second liner that is separated outside the chamber. The market offers different mechanical systems for compressing the films and cutting between the two elements to be separated, providing very high containment performance.
These circuits made with liners are made inside flexible or rigid chambers. The operations are carried out from the outside using EPDM or LDPE gloves and require the use of practical and ergonomic tools. For all operations involving the use of continuous liners, CSV Containment has developed a proprietary separation system called Twin Tie®. Designed for high containment, Twin Tie® differs from other crimping kits and safety seals, since it is easy to use and offers a one-stop solution for dealing with different sizes.
Applications of this double-barrier technique are also possible in dispensing isolators equipped with an inlet chamber, weighing chamber, and outlet chamber, where a very high degree of containment is required. The coaxial containment system via liner can be inserted into both flexible and rigid equipment. Both are capable of ensuring very high levels of containment; rigid containment systems achieve higher standards, but double-liner management is easier in flexible systems. Rigid counter chambers allow these operations to be carried out under vacuum, for example in case of accidents.
Liners produced by CSV Containment.
The double isolation barrier requires an outlet liner of adequate diameter to easily accommodate the contents from the inner liner. The length of the liners must be calculated to minimize liner changes and internal chamber encumbrances to provide the necessary maneuvering space for the operator. Therefore, just one liner per batch must be associated with the transfer batches to avoid intra-batch changing. The CSV Containment product line offers many suitable solutions to meet all these requirements, in addition to the possibility of custom-made liners according to customer requirements. For in-house operations, films with a maximum thickness of 80 to 90 microns are recommended to ensure better handling. Products made with components that make the film softer and more compressible while increasing its tightness are also preferred. CSV Containment can also deal with the processing of customer-supplied material to make dedicated continuous liners.
CSV Containment provides tailor-made solutions for pharmaceutical and fine chemical sectors in terms of containment. For more info: email@example.com